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Preventing Hypotension in Parturients With an Elevated Body Mass Index (BMI)

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01481740
First received: July 22, 2011
Last updated: September 14, 2016
Last verified: September 2016
Results First Received: September 14, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypotension
Interventions: Drug: Phenylephrine bolus
Drug: phenylephrine infusion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Phenylephrine Bolus Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
Phenylephrine Infusion phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus

Participant Flow:   Overall Study
    Phenylephrine Bolus   Phenylephrine Infusion
STARTED   90   88 
COMPLETED   79   81 
NOT COMPLETED   11   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Phenylephrine Bolus Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
Phenylephrine Infusion phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
Total Total of all reporting groups

Baseline Measures
   Phenylephrine Bolus   Phenylephrine Infusion   Total 
Overall Participants Analyzed 
[Units: Participants]
 79   81   160 
Age 
[Units: Years]
Mean (Standard Deviation)
 32  (6)   31  (5)   31  (5) 
Gender 
[Units: Participants]
     
Female   79   81   160 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
Canada   54   56   110 
United States   25   25   50 


  Outcome Measures
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1.  Primary:   Incidence of Nausea and Vomiting   [ Time Frame: intraoperative ]

2.  Primary:   Incidence of Nausea and Vomiting   [ Time Frame: 2 hrs postoperative ]

3.  Primary:   Incidence of Nausea and Vomiting   [ Time Frame: 24hrs postoperative ]

4.  Secondary:   Incidence of Hypotension   [ Time Frame: intraoperative - predelivery ]

5.  Secondary:   Incidence of Hypotension   [ Time Frame: intraoperative - postdelivery ]

6.  Secondary:   Neonatal Acidosis   [ Time Frame: intraoperative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Ronald B George
Organization: Department of Women's & Obstetric Anesthesia, IWK Health Centre
phone: 902-470-6627
e-mail: rbgeorge@dal.ca



Responsible Party: Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01481740     History of Changes
Other Study ID Numbers: 4999-01460
Study First Received: July 22, 2011
Results First Received: September 14, 2016
Last Updated: September 14, 2016
Health Authority: Canada: Ethics Review Committee